Method and apparatus for anastomosis

ABSTRACT

Apparatus and methods for performing a surgical anastomotic procedure are disclosed herein. Apparatus according to the present disclosure include at least one fastener including a first fastener portion having an anchoring leg portion, a second fastener portion including an anchoring leg portion, wherein the first and second fastener portions are operatively associated with one another to selectively fix the position of the first fastener portion relative to the second fastener portion. The apparatus has a first member for engaging the first fastener portion and a second member for engaging the second fastener portion. The first member and the second member are movable with respect to one another to move the first fastener portion and second fastener portion with respect to one another.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a National Stage Application of PCT/US 03/19516 under 35 USC§371(a), which claims priority of U.S. Provisional Patent ApplicationSer. No. 60/390,106 filed Jun. 19, 2002, now abandoned, the entirecontents of which are hereby incorporated by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to apparatus and methods used for joiningtissue portions and more particularly, to anastomotic devices andmethods for positioning and joining two hollow body parts.

2. Background of Related Art

Anastomosis is the bringing together and/or joining of two hollow ortubular structures. When it is desired to suture a body conduit,typically for attachment to another body conduit, sutures are placedaround the circumference of the conduit in order to maintain the patencyof its lumen or channel. It can be appreciated that the sutures made ontop of the conduit (i.e., on the side facing the surgeon) are maderelatively more easily than the sutures made underneath the conduit(i.e., on the side facing away from the surgeon).

The complexity of joining two body vessels is made manifestly apparentin a surgical procedure referred to generally as a radical prostatectomy(i.e., a well established surgical procedure for patients with localizedprostatic carcinoma). In general, radical prostatectomy proceduresrequire the removal of cancerous tissue while preserving sexual functionand continence in the patient. There are two primary types of radicalprostatectomy approaches for the removal of prostate cancer, theretropubic approach and the perineal approach.

In the retropubic approach, a long up-and-down incision is made in themidline of the abdomen from the navel to the pubic bone. After the lymphnodes have been removed for study by the pathologist and a determinationhas been made to proceed with the removal of the prostate gland, thespace underneath the pubic bone is cleaned and dissected and the removalof the entire prostate gland is generally begun at the end that isfarthest from the bladder, i.e., next to the external urethralsphincter. Next, the prostatic urethra is divided, the prostatic urethraand the prostate gland through which it goes are then pulled upwardstoward the bladder while the dissection continues behind the prostategland, separating it from the layer of tissue that is connected to therectum on its other side. As the dissection continues between theprostate and the rectum, the seminal vesicles, which are behind the baseof the bladder, will be removed along with the prostate gland. Once theseminal vesicles are free, the entire prostate gland and the seminalvesicles are removed. The bladder neck is then stitched closed to asmall enough diameter so that it is about the same size as the stump ofthe urethra from which the prostate was detached. The bladder neck isthen pulled down into the pelvis and positioned against the urethralstump and stitched thereto. This stitching is done typically around aFoley catheter which has been inserted through the penis all the wayinto the bladder.

In the perineal approach, an inverted “U” shaped incision is made goingright over the anus, with the center of the “U” about three centimetersabove the margin of the anus. The prostate gland is then freed from itssurrounding structures by gentle dissection, and the urethra at the endof the prostate farthest from the bladder is isolated and divided. Thebladder neck is freed from the prostate, and, once the prostate glandhas been removed and the bladder neck has been closed sufficiently sothat the size of its opening approximates the size of the urethralopening, the urethra and the bladder neck are stitched together. Onceagain, a Foley catheter is left in place postoperatively for about twoweeks.

In each of the above described procedures, it is the attachment of theurethral stump to the bladder neck which is particularly difficult andcomplex. This difficulty is complicated by the tendency of the urethralstump to retract into adjacent tissue. As a result, considerable timeand effort must be expended to re-expose the urethral stump and beginthe re-anastomosis procedure. Further complicating this procedure is thefact that the urethral stump is hidden beneath the pubic bone thusrequiring that the surgeon work at a difficult angle and in positionsthat are uncomfortable and limiting.

Various devices have been proposed for facilitating this procedure. InU.S. Pat. No. 5,591,179, issued to Edelstein, there is disclosed asuturing device including a shaft with portions defining an interiorchannel extending between a proximal and a distal end of the shaft. Thischannel includes a generally axial lumen which extends to the proximalend of the shaft and a generally transverse lumen which extends from theaxial lumen distally outwardly to an exit hole at the outer surface ofthe shaft. A needle and suture can be back loaded to the transverselumen of the channel while a generally non-compressible member can bemovably mounted in the axial lumen of the channel. At the proximal endof the shaft a handle is provided with means operative to push themember distally through the lumen to deploy or expel the needle.

In U.S. Pat. No. 4,911,164, issued to Roth, there is disclosed a sutureguide with a curved distal portion. The distal portion of the sutureguide has a plurality of exterior axial grooves which can be used toalign and guide a curved needle and attached suture. In order to drivethe urethral stump to an accessible position, the device is providedwith a plurality of outwardly extendable members which engage the lumenof the urethra. These members make it possible to push the urethralstump into approximation with the bladder neck.

In U.S. Pat. No. 5,047,039, issued to Avant et al., there is disclosed asurgical device for the ligation of a dorsal vein and subsequentanastomosis. This device contains a pair of enclosed needles each havingan attached suture which needles may be driven from the shaft of thedevice into adjacent tissue.

In general, none of the devices disclosed in the prior art referencesabove is simple to use or makes the anastomosis of the urethral stump tothe bladder neck easier. As such, each surgical procedure using priorart devices continues to be time consuming and requires great skill inorder to be performed. Accordingly, the need exists for anastomosisdevices which overcome the drawbacks of the prior art devices and whichare quick and simple to use.

SUMMARY

Apparatus and methods for performing a surgical anastomotic procedureare disclosed herein. According to one aspect of the present disclosure,an apparatus for approximating body vessels includes at least onefastener. Each fastener includes a first fastener portion having ananchoring leg portion, and a second fastener portion having an anchoringleg portion, wherein the first and second fastener portions areoperatively associated with one another for selectively fixing theposition of the first fastener portion and the second fastener portionwith respect to one another. The apparatus further includes a firstmember configured and adapted to engage the first fastener portion, anda second member configured and adapted to engage the second fastenerportion, the first member and the second member being movable withrespect one another to move the first fastener portion and secondfastener portion with respect to one another.

It is envisioned that each first fastener portion and second fastenerportion has a locking leg portion and a first position in which theanchoring leg portion is adjacent the locking leg portion and a secondposition in which the anchoring leg portion is spaced a distance fromthe locking leg portion.

Each of the anchoring leg portions of the first and second fastenerportions can include a sharpened tip, wherein the sharpened tips areoriented substantially toward one another. Each anchoring leg portioncan be integrally connected to the respective locking leg portion.

In certain embodiments, the apparatus further includes an insertionsleeve. Accordingly, it is envisioned that each anchoring leg portioncan be biased to a position spaced from the respective locking legportion and collapsible to a position in close proximity to therespective locking leg portion.

It is envisioned that each fastener can be made from stainless steel,titanium, polyglycolic acid and polylactic acid.

In certain embodiments, the first fastener portion and the secondfastener portion include inter-engaging fixing elements. The fixingelements can include a series of projections formed along a surface ofthe first fastener portion, and a locking passage formed along a surfaceof the second fastener portion, the locking passage being configured anddimensioned to receive an end of the first fastener portion therein. Thelocking passage can include at least one projection extending from aninner surface thereof and the at least one projection is configured anddimensioned to engage the series of projections formed along the surfaceof the first fastener portion. Desirably, the fixing elements are sawtoothed. Accordingly, the fixing elements permit movement of the firstfastener portion relative to the second fastener portion in a firstdirection, while preventing movement in a second direction.

It is envisioned that each of the first fastener portion and the secondfastener portion can have a locking leg portion pivotably connected tothe respective anchoring leg portion.

Each anchoring leg portion can include a suture secured thereto.

In certain embodiments, the apparatus can further include an insertionsleeve. It is envisioned that a plurality of fasteners can be radiallydisposed about the lumen of the insertion sleeve.

It is envisioned that each first fastener portion can include a lipextending from the first fastener portion and the first member caninclude an anvil having a hook formed at a distal end thereof forengaging the lip of the first fastener portion. It is further envisionedthat each second fastener portion can include a lip extending from thesecond fastener portion and the second member can include a pusherhaving a recess formed in a distal end thereof for engaging the lip ofthe second fastener portion.

In certain embodiments, the apparatus can further include fixingelements on each of the first and second fastener portions. The fixingelements can include a series of projections formed along a surface ofthe first fastener portion, and a locking passage formed along a surfaceof the second fastener portion, the locking passage being configured anddimensioned to receive an end of the locking leg portion of the firstfastener portion therein. The locking passage includes at least oneprojection extending from an inner surface thereof which at least oneprojection is configured and dimensioned to engage the series ofprojections formed along the surface of the first fastener portion. Thelocking passage is defined by a pair of side walls extending from thelocking leg portion of the second fastener portion and an end wallinterconnecting and extending between the pair of side walls, the atleast one projection of the locking passage being formed on an innersurface of the end wall.

According to another aspect of the present disclosure, a method ofapproximating a first body vessel and a second body vessel is provided.The method includes the step of providing an apparatus for approximatingthe first body vessel and the second body vessel. The apparatus includesat least one fastener having a first fastener portion having ananchoring leg portion, and a second fastener portion having an anchoringleg portion, wherein the first and second fastener portions areoperatively associated with one another for selectively fixing theposition of the first fastener portion and the second fastener portionwith respect to one another, a first member configured and adapted toengage the first fastener portion, and a second member configured andadapted to engage the second fastener portion, the first member and thesecond member being movable with respect to one another to move thefirst fastener portion and second fastener portion with respect to oneanother.

The method further includes the steps of passing the apparatus throughthe first body vessel and through an opening in the second body vesselsuch that the anchoring leg portion of the first fastener portion ispositioned within the second body vessel, withdrawing the first memberto drive the anchoring leg portion of the first fastener portion intothe wall of second body vessel, advancing the second member to drive theanchoring leg portion of the second fastener portion into the wall ofthe first body vessel, and approximating the first member and the secondmember to approximate the anchoring leg portions of the first and secondfastener portions with one another and to approximate the first andsecond body vessels with one another, wherein the fixing elements engageone another and inhibit separation of the first and second body vesselsfrom one another.

It is envisioned that the anchoring leg portions can be biased to anexpanded position and the fastener can be disposed within an insertionsleeve so as to maintain the fastener in a collapsed position. Themethod can further include the step of withdrawing the insertion sleeveso as to allow the anchoring leg portion to expand.

These and other features of the apparatus disclosed herein, will becomeapparent through reference to the following description of embodiments,the accompanying drawings and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure andtogether with the detailed description of the embodiments given below,serve to explain the principles of the present disclosure.

FIG. 1 is a top plan view of a fastener, in accordance with anembodiment of the present disclosure, shown in a separated condition;

FIG. 2 is a side elevational view of the fastener of FIG. 1;

FIG. 3 is a top plan view the fastener of FIGS. 1-2, shown in a coupledcondition;

FIG. 4 is a side elevational view of the fastener of FIGS. 1-3;

FIG. 5 is an enlarged cross-sectional view of the indicated area of FIG.3;

FIG. 6 is an enlarged end view of the fastener of FIGS. 1-5;

FIG. 7 is a cross-sectional side elevational view illustrating thepositioning of the insertion tool and fastener into a hollow body organ;

FIG. 8 is a cross-sectional side elevational view illustrating thepositioning of the insertion tool and the fastener as well as theexpansion of the distal of the fastener in the hollow body organ inorder to anchor the distal end of the fastener in the walls of thehollow body organ;

FIG. 9 is a cross-sectional side elevational view illustrating theexpansion of the proximal end of the fastener in order to anchor theproximal end of the fastener to the walls of the body lumen;

FIG. 10 is a cross-sectional side elevational view illustrating theapproximation of the hollow body organ to the body lumen;

FIG. 11 is a cross-sectional side elevational view illustrating theretraction of the insertion tool;

FIG. 12 is a cross-sectional side elevational view illustrating thefinal anastomosed hollow body organ and body lumen with the fasteneranchored in position;

FIG. 13A is a side elevational view of a proximal leg of a fastener inaccordance with an alternative embodiment of the present disclosure; and

FIG. 13B is a side elevational view of a distal leg of a fastener inaccordance with the alternative embodiment of the present disclosure.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed anastomosis apparatuswill now be described in detail with reference to the drawing figureswherein like reference numerals identify similar or identical elements.In the drawings and in the description which follows, the term“proximal”, as is traditional, will refer to the end of the surgicaldevice or instrument of the present disclosure which is closest to theoperator, while the term “distal” will refer to the end of the device orinstrument which is furthest from the operator.

An anastomosis apparatus 100, in accordance with an embodiment of thepresent disclosure, is shown in FIGS. 1-12. Although anastomosisapparatus 100 offers significant advantages to a radical prostatectomyprocedure, it will be understood that the device is applicable for usein any anastomotic procedure where two body vessels are to be broughttogether and joined.

As seen in FIGS. 1-6, anastomosis apparatus 100 includes at least onefastener 102 and preferably a plurality of fasteners 102 radiallydisposed about a lumen 184 of an insertion sleeve 180 (see FIG. 7). Eachfastener 102 includes a first fastener portion 104 and a second fastenerportion 106. First fastener portion 104 of fastener 102 includes alocking leg portion 108 and an anchoring leg portion 110 integrallyformed with locking leg portion 108. In particular, locking leg portion108 includes a proximal end 112 and a distal end 114 from whichanchoring leg portion 110 extends. Anchoring leg portion 110 includes adistal end 116 integrally coupled to distal end 114 of locking legportion 108 and a sharpened proximal tip 118. Desirably, sharpenedproximal tip 118 of anchoring leg portion 110 is oriented towardsproximal end 112 of locking leg portion 108. Anchoring leg portion 110has a first position “A” in which sharpened proximal tip 118 is spaced adistance from locking leg portion 108 and can be collapsed to a secondposition “C” (as seen in phantom in FIGS. 2 and 3) in which sharpenedproximal tip 118 is in close proximity to locking leg portion 108.

Preferably, locking leg portion 108 of first fastener portion 104includes fixing elements for engaging second fastener portion 106. Thefixing elements in certain embodiments comprise a series of projections120 formed along a side thereof and extending from proximal end 112toward distal end 114. First fastener portion 104 of fastener 102further preferably includes a lip 122 projecting distally from distalend 110 of locking leg portion 108.

Second fastener portion 106 of fasteners 102 includes a locking legportion 124 and an anchoring leg portion 126 integrally formed withlocking leg portion 124. In particular, locking leg portion 124 includesa distal end 128 and a proximal end 130 from which anchoring leg portion126 extends. Anchoring leg portion 126 includes a proximal end 132integrally coupled to proximal end 130 of locking leg portion 124 and asharpened distal tip 134. Desirably, sharpened distal tip 134 ofanchoring leg portion 126 is oriented towards distal end 128 of lockingleg portion 124. Anchoring leg portion 126 has a first position “A” inwhich sharpened distal tip 134 is spaced a distance from distal end 128of locking leg portion 124 and can be collapsed to a second position “C”(as seen in phantom in FIGS. 2 and 4) in which sharpened distal tip 134is in close proximity to locking leg portion 124.

Preferably, locking leg portion 124 of second fastener portion 106includes a locking passage 136 formed along a side surface thereof. Asseen in FIG. 6, locking passage 136 is defined by an upper wall 138extending from an upper surface of locking leg portion 124, a lower wall140 extending from a lower surface of locking leg portion 124 and aninterconnecting side wall 142 extending between the terminal ends ofupper wall 138 and lower wall 140. Locking passage 136 includes at leastone, and desirably a plurality of fixing elements for engaging thefixing elements of the first fastener portion 104. The locking passage136 shown has fixing elements in the form of a plurality of projections144 formed along an inner surface of interconnecting side wall 142 andoriented toward locking leg portion 124. Locking passage 136 is sizedand dimensioned to slidably receive end of first fastener portion 104therethough. In particular, when locking leg portion 108 of firstfastener portion 104 is inserted into locking passage 136 of secondfastener portion 106, projections 120 of locking leg portion 108 engageprojections 144 of locking passage 136 to thereby effectively lock firstfastener portion 104 of fastener 102 in position with respect to secondfastener portion 106 of fastener 102.

Similar to first fastener portion 104 of fastener 102, second fastenerportion 106 of fastener 102 includes a lip 148 projecting proximallyfrom proximal end 130 of locking leg portion 124.

As seen in FIG. 5, it is contemplated that projections 120 of lockingleg portion 108 and projections 144 of side wall 142 of locking passage136 are teeth-like (e.g., saw toothed) projections 146 a, 146 b,respectively, configured and adapted to permit locking leg portion 108to be inserted into locking passage 136 and hindering withdrawal oflocking leg portion 108 therefrom. In particular, projections 146 a, 146b are configured and adapted to permit locking leg portion 108 to slidein direction “D” while locking passage 136 is permitted to slide indirection “E”. However, once projections 146 a and projections 146 bengage one another, projections 146 a, 146 b prevent locking leg portion108 from sliding in a direction opposite to direction “D” and preventlocking passage 136 from sliding in the direction opposite from “E”. Inother words, projections 146 a, 146 b are configured and adapted toallow uni-directional movement of locking leg portion 108 relative tolocking passage 136 and in turn unidirectional movement of firstfastener portion 104 relative to second fastener portion 106.

While projections 120 of locking leg portion 108 and locking passage 136are shown and described as being formed along a side surface of firstfastener portion 104 and second fastener portion 106, respectively, itis envisioned and within the scope of the present disclosure thatprojections 120 can be provided along any surface of locking leg portion108 of first fastener portion 104 and locking passage 136 can beprovided along any surface of locking leg portion 124 of second fastenerportion 106.

First fastener portion 104 and second fastener portion 106 of fastener102 can be made from any surgical grade material, such as stainlesssteel or titanium. It is envisioned that first and second fastenerportions 104, 106 are preferably made from a medical gradebio-absorbable material, such as, for example, polyglycolic acid (PGA)and/or polylactic acid (PLA). Preferably, the material and dimensions offasteners 102 are selected such that fasteners 102 will dissolve after apredetermined period of time while retaining their structural integrityfor a period of time sufficient to assure proper healing of theanastomosis site.

As seen in phantom in FIG. 7, anastomosis apparatus 100 includes a firstmember or anvil 150, a second member or pusher 170, and a shaft 190 formounting the fasteners 102 in an insertion sleeve 180. The anvil 150 andpusher 170 are shown in phantom in FIGS. 3 and 4. Anvil 150 includes anelongate body portion 152 and a hook 154 formed at a distal end 156thereof. Hook 154 of anvil 150 is configured and adapted to engage lip120 of first fastener portion 104 of fastener 102. Pusher 170 includesan elongate body portion 172 and a recess 174 formed at a distal end 176thereof. Recess 174 of pusher 170 is configured and adapted to engagelip 146 of second fastener portion 106 of fastener 102.

As seen in FIGS. 7-11, insertion sleeve 180 includes a distal end 182, aproximal end (not shown) and defines a lumen 184 extending therethroughwhich defines a central axis. Shaft 190 is configured and adapted to beslidably received in lumen 184 of insertion sleeve 180. It is envisionedthat shaft 190 include a plurality of radially oriented longitudinallyextending grooves (not shown) formed therein. Accordingly, each grooveof shaft 190 can be configured and adapted to receive a respective anvil150, pusher 170 and fastener 102. Preferably, shaft 190 is sized suchthat when shaft 190 is inserted into sleeve 180, anchoring leg portion108 of first fastener portion 104 and anchoring leg portion 124 ofsecond fastener portion 106 are in the second position “C” (see FIG. 7).

Anvil 150 and pusher 170 are arranged with respect to one another so asto form a recess for receiving fastener 102 between hook 154 and recess174. Fastener 102 is disposed in the recess so that first fastenerportion 104 and second fastener portion 106 are engaged with oneanother, leaving room for advancing the anchoring leg portions towardone another. A plurality of fasteners 102 are disposed in insertionsleeve 180, with the shaft 190 disposed between the fasteners 102 andtheir corresponding anvil and pusher. (see FIG. 7).

A preferred method of use and operation of anastomosis apparatus 100 inperforming a radical prostatectomy anastomosis will now be described ingreater detail with reference to FIGS. 1-12 and in particular withreference to FIGS. 7-12. Anastomosis apparatus 100 can be used in eitherthe retropubic or the perineal prostatectomy approaches, or any approachin which the bladder and urethra must be approximated. With the prostateremoved, the bladder neck “N” of the bladder “B” is first reconstructedby everting the inner mucosal lining of bladder “B” and suturing it downto the outer wall of bladder “B”, using known surgical techniques.Likewise, urethral stump “S” of urethra “U” is reconstructed by evertingthe inner mucosal lining of urethral stump “S” and suturing it down tothe outer wall of urethra “U”, using known surgical techniques.

Preferably, with bladder neck “N” reconstructed, bladder neck “N” issized to properly accommodate and retain distal end 180 of sleeve 180within bladder “B” using a standard tennis racket type closure (i.e.,the opening of the bladder neck constituting the head of the tennisracket and a radial incision extending from the bladder neckconstituting the handle portion of the tennis racket). The size of thebladder neck will vary depending on the patient. Typically, the bladderneck “N” is sized to be approximately 7-8 mm in diameter.

With bladder neck “N” reconstructed, apparatus 100 is passedtrans-urethrally through urethra “U” until distal end 182 of insertionsleeve 180 extends out of urethral stump “S” and into bladder “B”through bladder neck “N”, as seen in FIG. 7.

With apparatus 100 so positioned, insertion sleeve 180 is withdrawn in aproximal direction to expose sharpened proximal tips 118 of firstfastener portions 104. The anchoring leg portions 110 are biased to thefirst position “A” so that when sharpened proximal tips 118 are exposedfrom within insertion sleeve 180, anchoring leg portions 110 of firstfastener portions 104 are deployed to the first position “A”. (see FIG.8). With anchoring leg portions 110 deployed, hooks 154 of anvils 150are withdrawn in a proximal direction to engage lips 122 of firstfastener portions 104 and to drive sharpened proximal tips 118 throughthe wall of bladder “B”, see FIG. 9.

As seen in FIG. 9, insertion sleeve 180 is further withdrawn in aproximal direction until sharpened distal tips 134 and anchoring legportion 126 of second fastener portion 106 are exposed. The anchoringleg portions 126 are biased to the first position “A” so that whenanchoring leg portions 126 are completely exposed from within insertionsleeve 180, anchoring leg portions 126 of second fastener portions 106are deployed to first position “A”. (see FIG. 9). With anchoring legportions 126 deployed, pushers 170 are advanced in, a distal directionto engage lips 148 and to drive sharpened distal tips 134 through thewall of urethral stump “S”.

With sharpened proximal tips 118 of first fastener portions 104penetrating the wall of bladder “B” and with sharpened distal tips 134penetrating the wall of urethral stump “S”, hooks 154 of anvils 150 areapproximated toward recesses 174 of pushers 170 to thereby approximateanchoring leg portions 110 of first fastener portion 104 and anchoringleg portions 126 of second fastener portion 106 towards one another.Concomitantly, as anchor leg portions 110 and 126 are approximatedtowards one another bladder neck “N” is approximated towards urethralstump “S”. (see FIG. 10). In accordance with the present disclosure,approximation of anchor legs 110 and 126 towards one another results inprojections 120 and 144 incrementally engaging one another andmaintaining the position of anchor leg 110 relative to anchor leg 126.Accordingly, projections 120 and 144 prevent bladder “B” from separatingfrom urethra “U”.

After bladder neck “N” has been approximated toward urethral stump “S”,pushers 170 and shaft 190 are withdrawn from insertion sleeve 180 andanvils 150 unhooked from lips 122. (see FIG. 11). Thereafter, anvils 150and insertion sleeve 180 are withdrawn from urethra “U”.

An alternate embodiment of a fastener 200, in accordance with thepresent disclosure, is shown in FIGS. 13A and 13B. Unlike fastener 102from above, fastener 200 includes a first fastener portion 202 and asecond fastener portion 204. First fastener portion 202 includes alocking leg portion 206 and an anchoring leg portion 208 pivotallycoupled to a proximal end of locking leg portion 206. In the embodimentshown, anchoring leg portion 208 is pivotally coupled to locking legportion 206 by a pivot pin 210, but other means known in the art mayalso be used. Alternatively, locking leg portion 206 or anchoring legportion 208 can be provided with an integrally formed pin that extendsoutwardly for receipt in an aperture formed in the other of locking legportion 206 or anchoring leg portion 208. First fastener portion 202includes a suture 212 connected to anchoring leg portion 208 for pullingon anchoring leg portion 208 and lifting a distal end of anchoring legportion 208 away from locking leg portion 206 (e.g., from first position“A” to second position “C”). It is contemplated that the proximal end oflocking leg portion 206 includes a stop (not shown) for stopping thelifting of anchoring leg portion 208 beyond a predetermined amount.

As seen in FIG. 13B, second fastener portion 204 includes a locking legportion 214 and an anchoring leg portion 216 pivotally coupled to adistal end of locking leg portion 214 by a pivot pin 218. Alternatively,locking leg portion 214 or anchoring leg portion 216 can be providedwith an integrally formed pin and extending outwardly for receipt in anaperture formed in the other of locking leg portion 214 or anchoring legportion 216. Second fastener portion 204 further includes a suture 220connected to anchoring leg portion 216, extending around the distal endof locking leg portion 214, for pulling on anchoring leg portion 216 andlifting a proximal end of anchoring leg portion 216 away from lockingleg portion 214 (e.g., from first position “A” to second position “C”).It is contemplated that the distal end of locking leg portion 214includes a stop (not shown) for stopping the lifting of anchoring legportion 216 beyond a predetermined amount.

While apparatus in accordance with the present disclosure have beendescribed as being used in connection with a radical prostatectomyprocedure, it is envisioned that apparatus having similar structures andmodes of operation can be used in various other surgical procedures. Itwill be understood that various modifications may be made to theembodiments of the presently disclosed anastomosis device and methoddisclosed herein. For example, one or more fasteners may be arranged inthe insertion sleeve. In further embodiments, the insertion sleeve issized to accommodate the fastener without requiring the anchoring legportions to collapse to position “C”. The fastener may comprise a singlepart with a corrugated, hinged or collapsible portion. The fasteners, incertain embodiments, comprise a fixing element comprising a separatepart.

Therefore, the above description should not be construed as limiting,but merely as an exemplification of a preferred embodiment. Thoseskilled in the art will envision other modifications within the scope ofthe present disclosure.

1. An apparatus for approximating body vessels, comprising: at least onefastener including: a first fastener portion having an anchoring legportion and a locking leg portion; a second fastener portion having ananchoring leg portion and a locking leg portion, wherein the first andsecond fastener portions are operatively associated with one another byan interconnecting feature allowing for selectively fixing the positionof the first fastener portion and the second fastener portion withrespect to one another; and wherein at least one of the first fastenerportion and the second fastener portion has a first position in whichthe anchoring leg portion is adjacent the locking leg portion and asecond position in which the anchoring leg portion is spaced a distancefrom the locking leg portion; a suture operably associated with theanchoring leg portion of at least one of the first fastener portion andthe second fastener portion wherein the anchoring leg portion of atleast one of the first and second fastener portions is repositionablebetween the first and second positions upon manipulation of the suture;a first member configured and adapted to engage the first fastenerportion; and a second member configured and adapted to engage the secondfastener portion, the first member and the second member being movablewith respect to one another to move the first fastener portion andsecond fastener portion with respect to one another.
 2. The apparatusaccording to claim 1, wherein each of the anchoring leg portions of thefirst and second fastener portions includes a sharpened tip, wherein thesharpened tips are oriented substantially toward one another.
 3. Theapparatus according to claim 1, wherein each fastener is made from thegroup of materials consisting of stainless steel, titanium, polyglycolicacid and polylactic acid.
 4. The apparatus according to claim 1, furthercomprising fixing elements on each of the first and second fastenerportions.
 5. The apparatus according to claim 4, therein the fixingelements include: a series projections formed along a surface of thefirst fastener portion; and a locking passage formed along a surface ofthe second fastener portion, the locking passage being configured anddimensioned to receive an end of the locking leg portion of the firstfastener portion therein, wherein the locking passage includes at leastone projection extending from an inner surface thereof which at leastone projection is configured and dimensioned to engage the series ofprojections formed along the surface of the first fastener portion. 6.The apparatus according to claim 5, wherein the locking passage isdefined by a pair of side walls extending from the locking leg portionof the second fastener portion and an end wall interconnecting andextending between the pair of side walls, the at least one projection ofthe locking passage being formed on an inner surface of the end wall. 7.The apparatus according to claim 4, wherein the fixing elements permitmovement of the first fastener portion relative to the second fastenerportion in a first direction and prevent movement in a second direction.8. The apparatus according to claim 1, wherein the first and secondfastener portions have a locking leg portion pivotably connected to therespective anchoring leg portion.
 9. The apparatus according to claim 8,wherein each of the first fastener portion and the second fastenerportion have a first position in which the anchoring leg portion isadjacent the locking leg portion and a second position in which theanchoring leg portion is spaced a distance from the locking leg portion.10. The apparatus according to claim 1, wherein the fastener portionincludes a lip extending from the first fastener portion, and whereinthe first member comprises an anvil having a hook formed at a distal endthereof engaging the lip of the first fastener portion.
 11. Theapparatus according to claim 10, wherein the second fastener portionincludes a lip extending from the second fastener portion, and whereinthe second member comprises a pusher having a recess formed in a distalend thereof for engaging the lip of the second fastener portion.
 12. Anapparatus for approximating body vessels, comprising: at least onefastener including: a first fastener portion having an anchoring legportion; a second fastener portion having an anchoring leg portion,wherein the first and second fastener portions are operativelyassociated with one another by an interconnecting feature allowing forselectively fixing the position of the first fastener portion and thesecond fastener portion with respect to one another; and wherein atleast one of the anchoring leg portions of the first and second fastenerportions includes a sharpened tip configured and dimensioned topenetrate body vessels; a suture operably associated with the anchoringleg portion of at least one of the first fastener portion and the secondfastener portion wherein the anchoring leg portion of at least one ofthe first and second fastener portions is repositionable between a firstand a second position upon manipulation of the suture; a first memberconfigured and adapted to engage the first fastener portion; and asecond member configured and adapted to engage the second fastenerportion, the first member and the second member being movable withrespect to one another to move the first fastener portion and secondfastener portion with respect to one another.
 13. An apparatus accordingto claim 12, wherein the sharpened tip is configured and dimensioned toanchor the apparatus relative to the body vessel.